UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013699
Receipt number R000015993
Scientific Title Genome wide analysis and combined omix analysis of patients with eosinophilic esophagitis and eosinophilic gastroenteritis
Date of disclosure of the study information 2014/04/12
Last modified on 2016/10/18 23:34:29

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Basic information

Public title

Genome wide analysis and combined omix analysis of patients with eosinophilic esophagitis and eosinophilic gastroenteritis

Acronym

Genome wide analysis and combined omix analysis of patients with eosinophilic esophagitis and eosinophilic gastroenteritis

Scientific Title

Genome wide analysis and combined omix analysis of patients with eosinophilic esophagitis and eosinophilic gastroenteritis

Scientific Title:Acronym

Genome wide analysis and combined omix analysis of patients with eosinophilic esophagitis and eosinophilic gastroenteritis

Region

Japan


Condition

Condition

eosinophilic gastrointestinal disorders

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To clarify the disease mechanisms through GWAS and OMICS analysis in patients with eosinophilic gastrointestinal disorders

Basic objectives2

Others

Basic objectives -Others

To identify risk variants for eosinophilic gastrointestinal disorders

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

genetic variants and disease susceptibility

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients diagnosed with eosinophilic gastrointestinal disorders based on the guideline
2. Patients with written informed consent

Key exclusion criteria

Nothing particular

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshikazu Kinoshita

Organization

Shimane University Faculty of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

89-1 Enya-cho, Izumo, Shimane 693-8501

TEL

0853-20-2190

Email

kinosita@med.shimane-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Norihisa Ishimura

Organization

Shimane University Faculty of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

89-1 Enya-cho, Izumo, Shimane 693-8501

TEL

0853-20-2190

Homepage URL


Email

ishimura@med.shiman-u.ac.jp


Sponsor or person

Institute

Department of Gastroenterology and Hepatology, Shimane University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Gastroenterology and Hepatology, Shimane University Faculty of Medicine

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

島根大学医学部(島根県), 京都大学医学部(京都府), 京都大学医学研究科附属ゲノム医学センター(京都府), 福岡大学筑紫病院(福岡県), 九州大学病院(福岡県), 東北労災病院(宮城県), 東北大学医学部(宮城県),大阪市立大学医学部(大阪府),山形大学医学部(山形県),藤田保健衛生大学(愛知県),兵庫医科大学(兵庫県),群馬大学(群馬県),慶應大学(東京都),松江市立病院(島根県)


Other administrative information

Date of disclosure of the study information

2014 Year 04 Month 12 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2013 Year 02 Month 06 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

prospective study


Management information

Registered date

2014 Year 04 Month 12 Day

Last modified on

2016 Year 10 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015993


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name